Data is collected for the purposes of research in this study and anonymized data is shared broadly with the research community after all identifying information has been removed. Within the firewalls of the Data Coordinating Center at Columbia University, identifying information is kept to link participants with their data results. The strictest data confidentiality standards are used to prevent disclosure of protected health information.
The study is designed to evaluate participants at baseline, 18 months, and 36 months after enrollment. Over these 3 years, the study is observational with no research study therapies used. However, lung function tests, computed tomography (CT) of the lung, collection of blood that will be stored, and answers to questionnaires will be collected. All specimens are labeled with a unique code to track progress through the study.
Individuals who desire to use biospecimens, questionnaire results, lung function or CT data for research are instructed to contact the study principal investigators. Primary biospecimen use will be for the A1BC investigators. However, the A1BC investigators, the National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) and the Alpha-1 Foundation are all committed to sharing of data and biospecimens if they can advance progress to a cure for Alpha-1. Data access should occur in collaboration with at least one A1BC clinical center investigator and should be discussed prior to making formal data or biosample requests.